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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 21, 2004
Date PostedMarch 11, 2005
Recall Status1 Terminated 3 on June 30, 2005
Recall NumberZ-0608-05
Recall Event ID 30664
510(K)NumberK932642 K972673 
ProductBayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-2272
Manufacturer Reason
for Recall		A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
FDA Determined
Cause 2		Other
ActionOwn name distributor consignees were notified on or about 1/3/05 via letter dated 12/21/04, and were requested to discontinue shipment of the product, notify all of their customers of the recall and to discard product. Roche consignees were notified via letter dated 12/21/04, requested to notify their customers if they had further distributed the product, and instructed to discard all inventory of product.
Quantity in Commerce3181 units
DistributionNationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code =
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